Multi-Therapeutic Areas ￨ Inpatient / Outpatient Studies ￨ Phase I IV Clinical Research Studies

Angina ￨ Alzheimer s ￨ Anxiety ￨ Dermatology ￨ Depression ￨ Insomnia ￨ HTN ￨ Male Erectile Dysfunction ￨ Migraines

Narcolepsy ￨ Parkinson s Disease ￨ Sleep Apnea ￨ Infectious Diseases ￨ Hemophilia / Oncology ￨ Vascular Dementia

• Dynamic Leader who offers a background in Clinical Research Coordination, Quality Data Collection, Research Staff / Ancillary Personnel Training, and Regulatory Compliance (e.g. SOPs, FDA, ICH, GCP); contributes talents in Source Document Development, Consent Writing, Audit Preparation, Study-Specific Documentation, and Data / Records Management; and exhibits an ability to see the big picture across all phases of clinical trials oversight.
• Top Performer who can make decisions to reflect positively on clinical operations in alignment with a trial s goals, and can showcase superior attention-to-detail and sharp analytical abilities to drive winning outcomes.
• Excellent Communicator who builds and sustains synergistic relationships with cross-functional clinical trials teams, research staff, ancillary personnel, and participants / patients; who excels in both autonomous and collaborative work environments; and who leads staff by example and with integrity to achieve objectives.

  Successfully directed 7 clinical trials for the Center of Disease (CDC) as the Lead CRC for Rady Children s Hospital.

  Utilized license and 17+ years of clinical research experience to open up a new, state-of-the-art research facility in 2010 for Universal Clinical Research that was successfully awarded 5 medical studies in the first year.

  Consistently ensured quality-focused clinical studies per comprehensive protocols, SOPs, and ICH / GCP standards.

  Personally handled all source document development and consent writing as DermTech s Clinical Site Director.

  Led research protocols and clinical trials in multi-therapeutic areas, Phases I-IV, and inpatient / outpatient studies for Pacific Research Network as a Certified Clinical Research Coordinator, and ensured FDA and / or GCP compliance.

Clinical Research Coordinator RN (CRC-RN)

  Capitalized on the opportunity to lead forward-thinking clinical studies on industry s Hemophilia / Clot-related research protocols, including continually serving as a liaison between the organization, investigators, research sponsors, and subjects, as well as planning, implementing, and managing 16 studies across diverse clinical trials.

  Expertly produced source documents, wrote consent forms, processed labs, completed data via online eCRFs / paper source, and created and submitted all documents to the IRB to meet clinical research administrative goals.

  Exhibited proven nursing experience to facilitate processes targeted toward comprehensive assessment, planning, implementation strategies, evaluation, and documentation of research in the Pediatric population.

Site Director

  Spearheaded new research facility start-up operations by meeting with numerous sponsors, buying and arranging calibration for new equipment, researching and setting up a temperature tracking system, ensuring PIs and Sub Is completed OSHA training, established training for GCP and SOP, and completed feasibility questionnaires.

  Expertly planned, coordinated, and managed subject recruiting and clinical project management functions required to conduct and complete all clinical trials which were instrumental in driving multifaceted trial success.

  Recruited, trained, mentored, and managed clinical staff and new hires to meet and / or exceed trial objectives.

  Ensured clinical studies were conducted to the highest quality per key protocols, SOPs and ICH / GCP standards.

Clinical Operations Supervisor I (2008 2009)

  Utilized broad scope of industry knowledge and dynamic healthcare acumen toward ensuring all practical steps of clinical studies were conducted to the highest possible quality and in accordance with core protocols, SOPs and ICH / GCP standards, as well as continually training, mentoring, and coaching results-focused staff.

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RN III Clinical Operations (2006 2008)

  Exhibited strong multitasking proficiencies toward handling varying aspects of study unit activities in the facilitation of clinical trials, including emphasizing a focus on the safety and welfare of all study participants.

  Completed essential cross-training initiatives in diverse daily tasks, and supported clinic operations as required.

Clinical Site Director ￨ Research RN

  Strategically steered implementation of research protocols and clinical trials in multi-therapeutic areas, Phases I-IV, and inpatient / outpatient studies; ensured compliance with FDA / GCP regulations and standards; and facilitated essential quality assurance and issues resolution to optimize clinical site research functions / efforts.

  Directed critical research staff / ancillary personnel training, and supported efficient preparations for key audits.

  Performed all physical exams on cosmetic and drug studies, and handled venipuncture / IV and lab processing.

Certified Clinical Research Coordinator

  Expertly managed and implemented comprehensive research protocols and clinical trials in multi-therapeutic areas, Phases I-IV, and inpatient / outpatient studies and complied with FDA and / or GCP regulations and standards.

  Drove clinical research success by researching staff / ancillary personnel training, handling source document development, facilitating audit preparation, resolving issues, and performing critical quality assurance efforts.

  Directed venipuncture and lab processing activities, and additionally led medication accountability studies.

Licensed Vocational Nurse ￨ Charge Nurse Sub-Acute Care Unit

  Contributed sharp analytical abilities toward dispensing high-volume medications and maintaining key logs.

  Developed and implemented individualized care plans, and performed treatment administration for patients.

  Directed a team of patient-oriented nurses aides, as well as participating on an IV team to meet patient needs.

  Handled all facets of tracheotomy care and ventilator care, and additionally facilitated patient NG tube feedings.

Licensed Vocational Nurse ￨ Charge Nurse

  Played a vital role in handling patient intakes / discharges, along with supervising a team of nursing assistants.

  Demonstrated experience in dispensing diverse medications, as well as logging all medications as necessary.

  Led preparations for comprehensive audits, and further facilitated group meetings to enhance productivity.

Associate of Science in Nursing

Licensed Vocational Nursing Program

Registered Nurse (State of Xxxxxx, License No. 617079)

Certified Clinical Research Coordinator ￨ Intravenous Certification (Current)

Basic EKG Interpretation ￨ BLS Certification (Current) ￨ IATA Certification (Current)

Microsoft Office (Word, Excel, PowerPoint, Outlook) ￨ EPIC ￨ Inform ￨ OpenClinica ￨ DATATRAK

Member, Association of Clinical Research Professionals

Excellent Professional References Provided Upon Request

Date

Hiring Agent Name

Company Name

Address

City/State/Zip Code

Dear__________________:

I am seeking a challenging [ Insert Job Title ] role, and am submitting my resume for your review.

I am excited to build a rewarding career with your company, and can offer cross-functional experience in Clinical Research Coordination, Quality Data Collection, Research Staff / Ancillary Personnel Training, and Regulatory Compliance (e.g. SOPs, FDA, ICH, GCP). I am also well-versed in Source Document Development, Consent Writing, Audit Preparation, Study-Specific Documentation, and Data / Records Management.

To complement my background, please note that I attained an Associate of Science in Nursing from Excelsior College and completed a rigorous Licensed Vocational Nursing Program at Grossmont Community College. I am a Registered Nurse in the State of Xxxxxx and a Certified Clinical Research Coordinator, among other credentials.

Recently, as a Clinical Research Coordinator / RN for Rady Children s Hospital Xxxxxx, I expertly led forward-thinking clinical studies on industry s Hemophilia / Clot-related research protocols, including continually serving as a liaison between the organization, investigators, research sponsors, and subjects. Within this role, I expertly produced source documents, wrote consent forms, processed labs, completed data via online eCRFs / paper source, and created and submitted all documents to the IRB to meet clinical research administrative goals. I also showcased my proven nursing experience to facilitate processes targeted toward comprehensive assessment, planning, implementation strategies, evaluation, and documentation of research in the Pediatric population.

A sampling of my achievements include:

  Successfully directing 7 clinical trials for the Center of Disease (CDC) as the Lead CRC.

  Personally leading planning, implementing, and managing of 16 studies across diverse clinical trials.

  Ensuring quality-focused clinical studies per comprehensive protocols, SOPs, and / or ICH / GCP standards.

[ Suggestion! Address Here Any Skills / Qualifications / Achievements Relevant to the Job Posting ]. As this is just an example of my abilities, please kindly refer to my enclosed resume for additional experience.

I look forward to hearing from you, and thank you in advance for your careful consideration.

Sincerely,

Yyyyyy x. yyyyyy